Joris van der Heijden

Designing Point of Care Diagnostics

Designing Point of Care DiagnosticsIt is all about the sample

Point-Of-Care Testing (POCT) has seen a large uptake over the past year driven by the need for on-site testing due to the COVID-19 pandemic. We see that often companies focus their attention on one specific sample type and subsequent sample preparation (e.g. blood or nasopharyngeal samples) and build a platform and market around the constraints of that sample type.

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Nick Allan

TPP: The secret to efficient diagnostic device design

efficient diagnostic device design2020 highlighted the importance of rapid diagnostics.  Many companies approached us in 2020 looking to develop a better COVID-19 diagnostic test.  No matter what the technology, state of development or size of the company, we have found that the key differentiator between a successful medical device product and an unsuccessful one, was having a good, well-defined Target Product Profile (TPP) going into the development cycle.

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Rade Gadzic

Quickly verify environmental stress cracking (ESC)

verify environmental stress cracking (ESC)The ability to quickly verify Environmental stress cracking (ESC) is important because it is one of the most common failure mechanisms in parts made of polymeric materials. Proper selection of polymers is crucial to the successful design, production and longevity of any product, but it is particularly vital to the purpose and usage of medical devices. In addition to standard mechanical and thermal properties, sensitivity to environmental stress cracking should be a major consideration, especially when dealing with polycarbonate.

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Nigel Syrotuck

RoHS 2 vs RoHS 3 impact on medical devices

Note: RoHS 3 is a colloquial term referring to Delegated Directive (EU) 2015/863, which is actually an amendment to RoHS 2 (Directive 2011/65/EU) rather than a standalone Directive. Though this terminology has become somewhat common (common enough to keep using the term here), it’s technically inaccurate. Originally published in April 2016, the article is updated on March 2, 2021 to include more details on the July 22, 2021 deadline. 

RohsRoHS 3 – The Trilogy is Complete

Are your medical devices RoHS compliant?

The Restriction of Hazardous Substances (RoHS) Directive has had a substantial and permanent effect on the materials that go into many of the electronic products we make.

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Virginia Anastassova

How to benefit from FDA ASCA (Accreditation Scheme for Conformity Assessment) Pilot Program

FDA launched their pilot  ASCA (Accreditation Scheme for Conformity Assessment) Program on September 25, 2020. The intent for the ASCA program is to utilize accredited third-party testing laboratories to assess premarket applicants’ declarations of conformity to consensus standards for safety, performance and biocompatibility. The final guidance outlining the accreditation scheme for the ASCA pilot program can be found here.

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